An observational study in Hemorrhage, sponsored by University Hospital Birmingham NHS Foundation Trust. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Observational
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Among 64 studies in Hemorrhage with a site in United Kingdom — 5 open to participants now, 7 under way, 5 of them phase 3. Hemorrhage · United Kingdom.
Among the 64 studies in Hemorrhage with a site in United Kingdom, this one is the 15th largest by enrollment of the 16 observational ones that give a count, is one of 2 that started in 2021, is one of 16 observational ones, and was the 56th registered.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
Browse Hemorrhage studies →5 of the 64 studies in Hemorrhage with a site in United Kingdom are open now. Recruiting first, the newest first:
Takeda · Sites in United Kingdom, United States, Australia and 12 more countries
Ages 18+
Takeda · Sites in United Kingdom, United States, Australia and 15 more countries
Ages 18+
Pfizer · Sites in United Kingdom, United States, Argentina and 20 more countries
Ages 1–17 · Men only
Icahn School of Medicine at Mount Sinai · Sites in United Kingdom, United States, Brazil and 2 more countries
Ages 18+
Population Health Research Institute · Sites in United Kingdom, Belgium, Botswana and 15 more countries
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 170 Hemorrhage studies recruiting now, 109 (64%) set no upper age limit and 40 (24%) stop at 75 or younger; 25 take children under 18; 21 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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64 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 215 across 397 observational studies indexed under Hemorrhage.
Median enrollment 105 across the 48 interventional studies, 485 across the 16 observational. Of the 52 that completed or were terminated, 14 (27%) have results posted.
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37 of 64 have an industry lead sponsor. The 10 most frequent:
University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
University Hospital Birmingham NHS Foundation Trust has 1 study filed under Hemorrhage — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 64 studies in Hemorrhage with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To evaluate the use of Purabond in ENT TORS for diagnostic and therapeutic procedures. Consecutive patients enrolled retrospectively via case note review. Outcome measures - primary and secondary haemorrhage, swallowing outcomes, need for nasogastric tube or tracheostomy, readmission.
Transoral robotic surgery (TORS) has been increasingly utilised in ear, nose and throat (ENT) Surgery over the past 20 years offering unprecedented 3-dimensional (3-D) views and enabling access to traditionally 'difficult-to-reach' tumours. It is now becoming a viable first line treatment option for oropharyngeal squamous cell carcinoma (OPSCC) compared to chemoradiotherapy. One of the main concerns is serious haemorrhage that can lead to death. PuraBond® (also known as PuraStat ®; 3D Matrix Ltd, Tokyo, Japan), which consists of the RADA16 family of synthetic peptides. PuraBond® is a self-assembling viscous solution that once applied on the surgical bed, it forms a transparent hydrogel 3-D matrix to achieve local haemostasis. Its transparent nature allows visualisation of the surgical field, permitting real-time assessment of intraoperative haemostasis. There are some studies demonstrating that it can promote healing. We aimed to assess the effect of Purabond in ENT TORS for diagnostic and therapeutic procedures such as oropharyngectomy and tongue base mucosectomy. Patients were enrolled from a single tertiary university hospital trust in the United Kingdom (University Hospitals Birmingham National Health Service Foundation Trust). Case notes for all patients were analysed retrospectively. Data extracted included patient demographics (age, sex, smoking history), procedure details (date, indication for surgery and type of TORS procedure) and tumour details (histopathology including p16 status and stage). The primary outcome measure was post-operative haemorrhage rate (primary; within 24 hours of surgery, and secondary; between 1-30 days post-surgery). Secondary outcome measures included, length of hospital stay (LOS), post-operative swallowing complications, in particular whether feeding tube insertion or tracheostomy was performed either prior to or within 30 days of surgery, hospital re- readmission rate within 30 days of surgery, and surgeon-reported ease of PuraBond® application. Descriptive statistical analysis was undertaken where applicable (mean, median, standard deviation) using Microsoft Excel® version 16.31.
All consecutive patients undergoing ENT transoral robotic surgery (TORS) with Purabond application between August 2021 - May 2022 at a single centre teaching university hospital National Health Service trust
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Application of Purabond to surgical field
Primary haemorrhage
Haemorrhage
Time frame: 24 hours post operatively
Secondary haemorrhage
Haemorrhage
Time frame: Day 1 to day 30 post operatively
Readmission
Hospital readmission
Time frame: Within 30 days post operatively
Feeding tube
Nasogastric tube insertion
Time frame: Within 30 days post operatively
Tracheostomy tube
Tracheostomy tube insertion
Time frame: Within 30 days post operatively
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in May 2022, 9 months.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Birmingham NHS Foundation Trust